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Protocols, Please

The Annals of Internal Medicine now requires its authors to publish their clinical trial protocols, Retraction Watch reports.

The COMPare Project, which examines changes to clinical trial protocols, had been critical of the Annals' approach, Retraction Watch adds. The project led by clinician and author Ben Goldacre had found that five trials published there had all switched what outcomes were measured. The COMPare team alerted the journal, but Goldacre told Retraction Watch at that time that its response was surprising.

"Annals have been the real surprise for everyone: dismissing concerns, writing error-laden 'rebuttals,' and even effectively telling trialists that they don't need to worry about replying to corrections on gross misreporting," Goldacre said then.

The journal's new guidelines now say that authors reporting clinical trial results "must submit the original pre-enrollment protocol … with any amendments that were made. All such material must be appropriately dated." It adds that those protocols would be published as article supplements.

Darren Taichman, the executive deputy editor of the Annals, tells Retraction Watch that these changes had been in the works for a while, but that the COMPare Project's findings sped their implementation up.

"[G]iven that interested readers sometimes encounter barriers despite a reproducible research statement saying that the protocol is available from authors, we will require (for trials submitted after April 19th) that the protocol accompany the published trial report," he adds.

The COMPare team says this is an improvement, but that more needs to be done.

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